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Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04651842
Collaborator
(none)
240
Enrollment
1
Location
12
Actual Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Full myocardial reperfusion with restoration of coronary microcirculatory function (CMF) is a therapeutic goal in ST-segment elevation myocardial infarction (STEMI).1 Despite the success of primary percutaneous coronary intervention (pPCI), it is not achieved in 30% to 50% of patients.2,3 Insulin resistance (IR) as a part of metabolic syndrome is an important risk factor for the development of cardiac and vascular impairments and carries ominous prognosis in the setting of acute myocardial infarction.4 As a part of metabolic syndrome, IR is associated with myocardial and microvascular injury after STEMI in clinical studies. As phenomenon per se, independent of other components of metabolic syndrome, IR was related to ischemic myocardial injury after elective PCI.5

Recently, IR in the early phase of acute coronary syndrome in non-diabetic patients, assessed by the homeostatic model assessment (HOMA) index, was established as an independent predictor of in-hospital mortality. This "acute" IR is a part of the acute glycometabolic response to stress, can be transient and can occur even in patients without chronic glycometabolic derangements.6

Acute IR comprises acute hyperglycemia and/or acute hyperinsulinemia; Hyperglycemia has the prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated.it also acknowledged direct acute negative cardiovascular effects as it is contributing to incomplete myocardial reperfusion and CMF impairment. The prognostic relevance of hyperinsulinemia in STEMI patients and its relationship with coronary flow are less well evaluated and acknowledged.7,8 Myocardial blush was first defined by Arnoud van't Hof etal . It is a qualitative visual assessment of the amount of contrast medium filling a territory supplied by a pericardial coronary artery.9 Myocardial blush grade is a valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty.

Reduced myocardial blush grade identifies patients at higher risk who need more aggressive treatment both during the procedure to improve myocardial perfusion and later for secondary prevention.10

We postulate that IR can occur in the early post pPCI period as a dynamic phenomenon even in non-diabetic patients, and be related to the development of microvascular injury. We have defined myocardial blush as a marker of coronary microvascular function, Accordingly, we have evaluated IR in relation to myocardial blush in non-diabetic STEMI patients treated by pPCI. as a primary end-point. The residual ST-segment elevation, post-TFC%; and MACE were secondary end points. The HOMA index is a simple and inexpensive marker of IR primary used in chronic states. It was recently validated against euglycemic hyperinsulinemic clamp in STEMI patients as feasible for assessing IR during myocardial infarction and therefore used in the current study.11

Condition or Disease Intervention/Treatment Phase
  • Device: PCI

Detailed Description

Myocardial blush grade is valuable tool for assessing coronary microvasculature and myocardial perfusion in patients undergoing coronary angiography and angioplasty and its reduction identifies patients at high risk. In this study we investigate the association of acute insulin resistance with myocardial blush grade and outcome in non-diabetic patients with ST-segment elevation myocardial infarction (STEMI).

Study Design

Study Type:
Observational
Actual Enrollment :
240 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Impact of Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
HOMA IR high

classified based on equal tertile of HOMA IR level into 3 equal groups ( high>6.6)

Device: PCI
Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
Other Names:
  • primary Insulin resistance

    		•
    HOMA IR intermediate

    classified based on equal tertile of HOMA IR level into 3 equal groups ( intermediate 4.6-6.6, )

    Device: PCI
    Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
    Other Names:
  • primary Insulin resistance

    		•
    HOMA IR low

    classified based on equal tertile of HOMA IR level into 3 equal groups (low ≤ 4.6, )

    Device: PCI
    Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
    Other Names:
  • primary Insulin resistance

    		•

    Outcome Measures

    Primary Outcome Measures

    1. arrythmia,LVF,Pulmonary edema,Cardiogenic shock, In hospital re-infarction,In hospital stent thrombosis [May2018 to May 2019]

    Secondary Outcome Measures

    1. In hospial mortality [May 2018 to May2019]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • This cross-sectional comparative study included 240 non-diabetic patients with acute STEMI of both sexes and different ages selected from cardiology department in Assiut University Hospital who underwent primary percutaneous coronary intervention (PCI) between first of May 2018 and first of May 2019.
    Exclusion Criteria:
    • Patients were excluded from this study if they had diabetes mellitus; renal insufficiency (creatinine >2 mg/dl); advanced hepatic dysfunction; taken anti-oxidant supplement/therapy within the past 4 weeks before enrollment; pregnant; were alcoholic; had allergy to radiographic contrast; uncooperative patient or patient refusal; also if they had malignancy; chronic heart failure or cardiomyopathy; prior myocardial infarction and diseases requiring steroid therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Soher Moustafa Kasem, Prof, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04651842
    Other Study ID Numbers:
    • Insulin resistance and PCI
    First Posted:
    Dec 3, 2020
    Last Update Posted:
    Dec 3, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Insulin Resistance
    Insulin

    Study Results

    No Results Posted as of Dec 3, 2020